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Brain blood flow mystery: does metabolic syndrome hit women harder?

NCT ID NCT07218653

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 5 times

Summary

This early-phase study looks at whether metabolic syndrome reduces brain blood flow more in women than in men. Researchers will use MRI scans and a drug called indomethacin to test this in 72 healthy adults and those with metabolic syndrome. The goal is to understand sex differences in brain health, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Indomethacin
What this could lead to
If successful, this study could reveal why metabolic syndrome harms brain blood flow more in women, pointing toward sex-specific prevention or treatment strategies.
What could go wrong
This is a very early, small study (72 people) that measures biological signals, not health outcomes. Results may not lead to any direct treatment or apply to broader populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (Healthy Controls): * 18-45 years old * Normal fasting values for blood glucose (less than 100 g/dl) * Normal values for lipids (LDL cholesterol less than 130 mg/dl, triglycerides less than 150 mg/dl) and HDL (men greater than 40, women greater than 50 mg/dl) * Women must have a predictable menstrual cycle. Females will be studied on cycle days 1-7 to minimize sex hormone differences and their potential confounding effects on vascular outcomes. Oral contraceptives are allowed, and women will be studied during their placebo phase. Inclusion Criteria (Participants with Metabolic Syndrome): * 18-45 years old * Meet at least 3 of the 5 ATP MetSyn criteria. These are: 1. Waist circumference greater than 102 cm (males) or 82 cm (females) 2. Triglycerides greater than 150 mg/dL 3. HDL cholesterol less than 40 mg/dL (males) or 50 mg/dL (females) 4. Blood pressure greater than or equal to 130/85 mmHg 5. Fasting plasma glucose greater than 110 mg/dL Exclusion Criteria (Healthy Controls): * Body Mass Index (BMI) greater than or equal to 25 kg/m2 * Blood pressure over 130/80 mmHg * Meeting any of the 5 MetSyn criteria listed above. Exclusion Criteria (all participants): * Current smoker, defined as more than 5 cigarettes over past 30 days * Current diagnosis or history of: * peripheral vascular disease * hepatic disease * renal disease * lung disease * gastrointestinal disorders/bleeding * hematologic disease * stroke * myocardial infarction * coronary heart disease * congestive heart failure * heart surgery * sleep apnea * autoimmune diseases * HIV * traumatic brain injury, concussion, stroke, or seizures * Asthma * Polycystic ovarian syndrome * Type II diabetes * Currently pregnant or breastfeeding * Current musculoskeletal injury * Medication use known to influence cardiovascular function, other than contraceptive hormones. Broadly, the classes of drugs relate to treating blood pressure, diabetes, cholesterol. * Claustrophobia * Lactose intolerance * Magnesium-restricted diet

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Wisconsin

    Madison, Wisconsin, 53706, United States

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Other studies related to the condition(s) this trial covers.